Total Intravenous Anesthesia in Percutaneous Transhepatic... | NCT03103672

Studies
Total Intravenous Anesthesia in Percutaneous Transhepatic Cholangiography

NCT03103672

Sponsor

Inonu University

Status

Unknown status

Last Update Posted

Apr 5, 2022Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Percutaneous Transhepatic Cholangiography

Interventions

Percutaneous transhepatic cholangiography

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2017Actual

Primary Completion Date

Nov 1, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Mar 31, 2017

First Submission Date that Met QC Criteria

Apr 5, 2017

First Posted Date

Apr 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2022

Last Update Posted Date

Apr 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yusuf Ziya ÇOLAK, Department of Anesthesiology, Inonu Univercity, School of Medicine, Inonu UniversityPrincipal Investigator

Lead Sponsor

Inonu UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Percutaneous transhepatic cholangiography is a disturbing procedure for patients.

TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by hemodynamic stability and better compilation profile The purpose of this study; To compare total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous transhepatic cholangiography under general anesthesia.

Detailed Description

Percutaneous transhepatic cholangiography is a disturbing procedure for patients. Especially pain at the time of dilation can be a serious problem. These situations may be required local anesthetics, intravenous narcotics and sedatives or general anesthesia (1).

TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by hemodynamic stability and better compilation profile (2).

The purpose of this study; To compare total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous transhepatic cholangiography under general anesthesia and Determine their advantages and disadvantages.

Michael J. Lee, Peter R. Mueller, Sanjay Saini, Peter F. Hahn, Stewen L. Dawson. Percutaneous Dilatation of Benign Biliary Strictures: Single-Season Therapy with General Anesthesia. AJR: 157, December 1991: 1263-1266
Xiaoqian Deng, Tao Zhu. Clinical comparison of propofol-remifentanil TCI with sevoflurane induction / maintenance anesthesia in laparoscopic cholecystectomy. Pak J Med Sci 2014 Vol. 30 No. 5: 1017-1021

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Groupe I		Patients who will receive inhalation anesthesia	Procedure: Percutaneous transhepatic cholangiography
Groupe 2		Patients who will receive total intravenous anesthesia	Procedure: Percutaneous transhepatic cholangiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous transhepatic cholangiography	Procedure	Percutaneous transhepatic cholangiography (PTC) can be performed via the right midaxillary approach, though a subxiphoid approach is occasionally needed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recovery time from anesthesia	Time for Modified Aldrete Score 9 and over	up to postoperative 1 hours

Secondary Outcomes

Measure	Description	Time Frame
Heart rate	Every 5 minutes during the process	up to postoperative 1 hours
Mean blood pressure	Every 5 minutes during the process

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients undergoing percutaneous transhepatic cholangiography with general anesthesia

Exclusion Criteria:

Essential data were missing
Patient participating in other research projects
Drug allergy
Anesthetic complication story

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing percutaneous transhepatic cholangiography

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yusuf Z Çolak, MD	Department of Anesthesia, İnonu Univercity, School of Medicine	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided